Menthol and Non-Menthol Cigarette Smoking in Young Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 199
- 试验地点
- 2
- 主要终点
- Subjective Response to Smoking Cigarettes From the Cigarette Evaluation Scale
研究概览
简要总结
This study focuses on menthol (n = 125) and non-menthol (n = 125) smoking young adults (YAs; defined here as ages 18 to 26).
详细描述
The study will occur in three phases.
In session 1 of Phase 1, participants will engage in ad libitum smoking session of one's preferred cigarette brand (menthol or non-menthol). In session 2, participants will take several puffs each of a commercially available menthol and non-menthol cigarette (i.e., Camel Crush) and complete a complete a series of pre-post smoking questionnaires, and in Session 3 participants will complete a computerized task to measure perceptions of cigarette smoking. For the computerized task, participants will be able to "win" points toward earning puffs of a cigarette and will be able to smoke puffs earned. Participants will be asked to abstain from smoking for at least 12 hours before each in-person visit.
Phase 2 participants will engage in 14 days of surveys they will complete on their cell to measure different aspects of smoking behavior. These surveys will happen twice a day at random times.
For phase 3, participants will complete an assessment of smoking behavior and related factors 6-months after the baseline assessment either in-person, in the laboratory, or via telephone or online (if in-person follow-up is not viable).
The order in which phases occur differed was a result of COVID-19 restrictions on data collection. For some participants, they started EMA first and then began laboratory data collection when in-person was allowed. For others, they started laboratory data collection when COVID restrictions were lifted. Thus, the participant flow may appear unbalanced.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 26 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Ages 18-26
- •Currently smoke cigarettes "everyday" or "somedays"
- •A strong preference for menthol or non-menthol cigarettes
- •able to read and understand the consent form
- •willingness to abstain from nicotine or tobacco products for at least 12 hours prior to smoking sessions
排除标准
- •Current use of nicotine replacement therapy
- •Pregnant or planning to become pregnant; or breastfeeding
- •self-reported diagnosis of lung disease, including asthma, cystic fibrosis, or chronic obstructive pulmonary disease; or
- •self-reported history of cardiac event or distress within the past 3-months
结局指标
主要结局
Subjective Response to Smoking Cigarettes From the Cigarette Evaluation Scale
时间窗: immediately after smoking usual brand cigarette, at baseline
ratings of subjective satisfaction from smoking cigarettes, 1= not at all to 7 = extremely. Higher scores indicate greater positive subjective response. The minimum score is 1and the maximum score is 7.
Average Daily Subjective Response From Smoking
时间窗: Phase 2 daily diary surveys (estimated 2-4 weeks after baseline)
average daily scores of subjective reward from smoking from daily diary surveys, 1= not at all to 7 = extremely. Higher scores indicate greater positive subjective response. Averaged across 14 days.
Highest Trial Competed for a Menthol Cigarette Puff in the Choice Task (Relative Reinforcing Value for Menthol Cigarettes)
时间窗: Lab session 3 (estimated average 1-4 weeks after baseline)
Participants completed a choice task assessing willingness to "work" to click targets on a computer screen to earn menthol or non-menthol cigarette puffs. The relative reinforcing value for menthol was defined by the Breakpoint, or the highest trial (out of 10 trials) completed for a menthol cigarette puff.
Past 30-day Cigarette Smoking Frequency
时间窗: 6-month follow-up survey (6-months post-baseline)
Number of days smoked cigarettes in the past 30-days
Puff Topography
时间窗: Laboratory session 1 (up to 4 weeks after baseline)
Number of cigarette puffs after smoking one's preferred brand/flavor during lab session 1, Phase 1.
次要结局
- Number of Clicks for Menthol Cigarette Puffs on the Behavioral Choice Task(immediately after completing the behavioral economic choice task, lab session 3 (estimated average 1-4 weeks after baseline))
- Quantity of Past 30-day Tobacco Product Use(6-month follow-up (6-months post-baseline))
- Number of Participants With Intentions to Smoke Menthol Cigarettes(6-month follow-up (6-months post-baseline))
- Cigarettes Per Day(Phase 2 daily diary surveys (estimated 2-4 weeks after baseline))
- Average Daily Craving From Smoking(Phase 2 daily diary surveys (estimated 2-4 weeks after baseline))